Ischemic Heart Disease (IHD)Phase 2NCT05885854
XTR003 PET Radiotracer for the Detection of Viable Myocardium
A Phase 2 study testing XTR003 in people with Ischemic Heart Disease (IHD), run by Sinotau Pharmaceutical Group at 1 site in China.
Trial summary
The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease (IHD)
- What is being tested?
- XTR003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 5 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old men and women.
- The diagnosis and assessment of the disease meet any of the following criteria:
- Patients who meet the diagnostic criteria for NSTEMI are stable and require further imaging. (b) Patients with old myocardial infarction confirmed by medical history or imaging examination and now in the stable stage. (c) Patients diagnosed with total coronary occlusions based on coronary angiography showing anterior flow occlusion segment with TIMI grade 0 or coronary CTA examination showing complete coronary artery occlusion.
- The rest 99mTc-Sestamibi (MIBI) SPECT imaging has been completed in the past month and no imaging technical issues were leading to poor image quality. Image indicated myocardial perfusion defect of ≥ 2 segments or total resting perfusion score (SRS) ≥4.
- The patient has completed glucose-loaded 18F-FDG myocardial metabolic PET imaging in the last month and has not failed to diagnose because of poor image quality due to technical problems with the imaging, except for his own glucose regulation.
- Patients who can communicate properly with the investigators, understand and follow the study requirements, voluntarily participate, and understand and sign the informed consent.
Who cannot join
- Patients with other preexisting cardiovascular diseases including but not limited to dilated or hypertrophic cardiomyopathy, pericarditis, aortic dissection, uncontrolled severe arrhythmias, and congenital heart disease are deemed not eligible for the study by the principal investigator.
- Patients with severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., are deemed not eligible for the study by the principal investigator.
- Patients with severe or unstable central nervous system diseases, including but not limited to unstable cerebrovascular diseases, active epilepsy, infectious diseases of the central nervous system, and central nervous system, and central nervous system disease associated with neuropathy or limb movement disorders are deemed not eligible for the study by the principal investigator.
- Patients with severe hemorrhagic diseases or coagulation disorders, including but not limited to purpura, hemophilia, and deficiency in vitamin K are deemed not eligible for the study by the principal investigator.
- Patients with fever or active infectious diseases are deemed not eligible for the study by the principal investigator.
- Patients with serious disorders of organ systems other than those described above and who are deemed not eligible for the study by the principal investigator.
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- Hematologic antigen/antibody test meets either of the following criteria: anti- HIV antibody (+) and syphilis antibody (+) are deemed not eligible for the study by the principal investigator.
- Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years.
- Pregnant or lactating women.
- People with mental disorders or poor compliance.
- Men and women of reproductive age refused to adopt contraceptive plans during the study period and for 6 months after the study ended.
- Other circumstances that the investigator considers inappropriate for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300456
About this study
Official title: Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium
The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD).
Read the detailed description
The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium.
This is an exploratory, single-arm, open-label, phase II clinical study with the following objectives:
- To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
- To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD.
- To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium.
- Conditions
- Ischemic Heart Disease (IHD)
- Being tested
- XTR003
- Keywords
- Coronary Artery Disease (CAD), Positron Emission Tomography (PET), XTR003 PET myocardial fatty-acid tracer, 18F-Fluorodeoxyglucose (18F-FDG), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Old Myocardial Infarction (OMI), Total Coronary Occlusions (TCO)
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTR003Drug
Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest;
- Initial intravenous injection of 18F-FDG to each subject with a dose range of 2.0-3.0 mCi (74-111 MBq). Each patient will be imaged with PET for 10 minutes at 50-70 minutes after the injection.
- In few minutes, a single intravenous bolus injection of XTR003 will follow and administer to each patient with a dose range of 6.0-8.0 mCi (222-296 MBq). Each patient will be immediately imaged with PET for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| XTR003; At rest | Experimental | 1. Injection with XTR003 to investigate myocardial fatty-acid metabolism in patients with known IHD.
2. Adjunct injection with 18F-FDG to investigate and trace myocardial glucose metabolism in patients with known IHD.
The study population consisted of 50 participants from the following category of patients: (1) Patients with Non-ST elevation myocardial infarction (NSTEMI) (2) Patients with old myocardial infarction (3) Patients with total occlusions of coronary arteries. Receives: Drug: XTR003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the sensitivity of combining XTR003/FDG PET imaging
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
Measured: Day 1
To investigate the specificity of combining XTR003/FDG PET imaging
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
Measured: Day 1
Secondary outcomes (1)
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Safety parameters included adverse events, vital signs (body temperature, blood pressure, respiration rate, pulse rate), physical examinations, laboratory tests (serum cardiac biomarkers, cardiac troponin I, serum biochemistry, haematology, and urinalysis) and electrocardiograms.
Measured: Up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start15 Dec 2021
- Primary completion4 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart Disease (IHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885854
- Sponsor's protocol ID
- STB-XTR003-201
- Status last verified
- May 2023
- First submitted
- 25 Dec 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Application of XTR003 as a Novel PET Myocardial Fatty Acid Metabolism Imaging Agent for the Detection of Viable Myocardium
- ClinicalTrials.gov ID
- NCT05885854
- Acronym / sponsor ID
- STB-XTR003-201
- Conditions
- Ischemic Heart Disease (IHD)
- Keywords
- Coronary Artery Disease (CAD), Positron Emission Tomography (PET), XTR003 PET myocardial fatty-acid tracer, 18F-Fluorodeoxyglucose (18F-FDG), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Old Myocardial Infarction (OMI), Total Coronary Occlusions (TCO)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed to explore the clinical feasibility of XTR003, a PET myocardial fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart disease (IHD).
Detailed description
The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient preparation protocols present challenges in certain patients such as patients with type I and II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable myocardium.
This is an exploratory, single-arm, open-label, phase II clinical study with the following objectives:
- To explore the clinical feasibility of XTR003 for the detection of viable myocardium in patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
- To evaluate the safety and adverse events incidence of XTR003 in patients with known IHD.
- To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining imaging in detecting viable myocardium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XTR003; At rest | Experimental | Drug: XTR0031. Injection with XTR003 to investigate myocardial fatty-acid metabolism in patients with known IHD. 2. Adjunct injection with 18F-FDG to investigate and trace myocardial glucose metabolism in patients with known IHD. The study population consisted of 50 participants from the following category of patients: (1) Patients with Non-ST elevation myocardial infarction (NSTEMI) (2) Patients with old myocardial infarction (3) Patients with total occlusions of coronary arteries. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old men and women.
- The diagnosis and assessment of the disease meet any of the following criteria:
- The rest 99mTc-Sestamibi (MIBI) SPECT imaging has been completed in the past month and no imaging technical issues were leading to poor image quality. Image indicated myocardial perfusion defect of ≥ 2 segments or total resting perfusion score (SRS) ≥4.
- The patient has completed glucose-loaded 18F-FDG myocardial metabolic PET imaging in the last month and has not failed to diagnose because of poor image quality due to technical problems with the imaging, except for his own glucose regulation.
- Patients who can communicate properly with the investigators, understand and follow the study requirements, voluntarily participate, and understand and sign the informed consent.
Key exclusion criteria (12 listed)
- Patients with other preexisting cardiovascular diseases including but not limited to dilated or hypertrophic cardiomyopathy, pericarditis, aortic dissection, uncontrolled severe arrhythmias, and congenital heart disease are deemed not eligible for the study by the principal investigator.
- Patients with severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., are deemed not eligible for the study by the principal investigator.
- Patients with severe or unstable central nervous system diseases, including but not limited to unstable cerebrovascular diseases, active epilepsy, infectious diseases of the central nervous system, and central nervous system, and central nervous system disease associated with neuropathy or limb movement disorders are deemed not eligible for the study by the principal investigator.
- Patients with severe hemorrhagic diseases or coagulation disorders, including but not limited to purpura, hemophilia, and deficiency in vitamin K are deemed not eligible for the study by the principal investigator.
- Patients with fever or active infectious diseases are deemed not eligible for the study by the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTR003Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest; 1. Initial intravenous injection of 18F-FDG to each subject with a dose range of 2.0-3.0 mCi (74-111 MBq). Each patient will be imaged with PET for 10 minutes at 50-70 minutes after the injection. 2. In few minutes, a single intravenous bolus injection of XTR003 will follow and administer to each patient with a dose range of 6.0-8.0 mCi (222-296 MBq). Each patient will be immediately imaged with PET for 15 minutes. | Drug | XTR003; At rest |
Primary outcome
To investigate the sensitivity of combining XTR003/FDG PET imaging
Time frame: Day 1
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
To investigate the specificity of combining XTR003/FDG PET imaging
Time frame: Day 1
To simultaneously trace fatty-acid and glucose metabolisms for the detection of viable myocardium in IHD patients with NSTEMI, old myocardial infarction, or total occlusions of coronary arteries.
1 secondary outcome
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Time frame: Up to 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XTR003 in people with Ischemic Heart Disease (IHD), run by Sinotau Pharmaceutical Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the sensitivity of combining XTR003/FDG PET imaging (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.